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AstraZeneca vaccine approved by European Medicines Agency as ‘safe and effective’

The EU’s drug watchdog says it is still convinced the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks following an investigation into reports of blood disorders that prompted more than a dozen countries to suspend its use.

The news came as the European Medicines Agency (EMA) director Emer Cooke said the watchdog could not definitively rule out a link between blood clot incidents and the vaccine in its investigation into 30 cases of a rare blood clotting condition.

But she said in a briefing the “clear” conclusion of the review was that the vaccine “benefits in protecting people from COVID-19 with the associated risk of death or hospitalisation outweighs the possible risks”.

The agency will however update its guidance to include an explanation about the potential risks on both the patient leaflet and in the information for healthcare professionals, she said.

“This is a safe and effective vaccine,” said Cooke.

A dose of the AstraZeneca COVID-19 vaccine ready for use. Credit: Alastair Grant/AP

The agency has been under growing pressure to clear up safety concerns after a small number of reports in recent weeks of bleeding, blood clots and low platelet counts in people who have received the shot.

The agency’s review covering 5 million people, included 30 cases of unusual blood disorders in people in the European Economic Area (EEA), which links 30 European countries.

The EMA’s focus and primary concern has been on cases of blood clots in the head, a rare condition that’s difficult to treat called cerebral venous thrombosis (CVT) or a subform known as cerebral venous sinus thrombosis (CVST).

More than 45 million of the jabs have been administered across the EEA.

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